Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemot

FDA device recall Z-0970-2012 · posted 2012-02-07 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution.

Action taken

CSZ sent an "URGENT: FIELD ACTION NOTICE" letter dated January 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to become familiar with the amended manual page and to get approvals from the Institutional Review Board before further use of the device. Additionally, a response form was enclosed with the letter for customers to complete and return via fax to (513)772-9119. Contact CSZ Service Department at 1-800-989-7373 for questions regarding this notice.

Root cause

Software design

Status

Terminated

Product code

DWJ

Quantity affected

A total of 20 devices were distributed in the U.S. & 3 units were distributed internationally.

Distribution

Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.

Date initiated

2011-10-27

Date posted

2012-02-07

Date terminated

2013-02-26

Location

Cincinnati, OH